The Food and Drug Administration is warning women and doctors that devices on the market purporting to make cosmetic alterations to the vagina have not been approved by regulators for that purpose and could result in painful side effects.
The agency has warned seven companies that their laser- or radiofrequency-based products are inappropriately being marketed as providing “vaginal rejuvenation” procedures. The companies have claimed that the devices will tighten the vagina or treat symptoms from menopause, urinary incontinence, or sexual function.
The FDA also has reports of incidences in which the devices are being marketed to women who have been treated for breast cancer and are having signs of early menopause.
“The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” FDA Commissioner Scott Gottlieb said in a blog.
No nonsurgical devices on the market have been approved by the FDA to treat any of these conditions. These types of devices have instead been approved to destroy genital warts, as well as precancerous cervical or vaginal tissue.
The FDA has found that when used outside of the purpose for which they were approved, the devices have led to burning of the vagina, scarring, and pain during sex or urination.
“We are deeply concerned women are being harmed,” Gottlieb said.
The companies — which include Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen — have 30 days to respond to the FDA concerns. If they do not, then the agency will take other measures, which could include asking the companies to take devices off the market entirely.
The agency is asking the public to report any incidents they have had with the devices.
